Abstract

Introduction: Noninvasive tests are increasingly used to assess liver fibrosis and determine prognosis but suggested test thresholds vary. We describe the selection of standardized thresholds for the Enhanced Liver Fibrosis (ELF) test for the detection of liver fibrosis and for prognostication in chronic liver disease.

Methods: A Delphi method was used to identify thresholds for the ELF test to predict histological liver fibrosis stages, including cirrhosis, using data derived from 921 patients in the EUROGOLF cohort. These thresholds were then used to determine the prognostic performance of ELF in a subset of 457 patients followed for a mean of 5 years.

Results: The Delphi panel selected sensitivity of 85% for the detection of fibrosis and >95% specificity for cirrhosis. The corresponding thresholds were 7.7, 9.8, and 11.3. Eighty-five percent of patients with mild or worse fibrosis had an ELF score ≥7.7. The sensitivity for cirrhosis of ELF ≥9.8 was 76%. ELF ≥11.3 was 97% specific for cirrhosis. ELF scores show a near-linear relationship with Ishak fibrosis stages. Relative to the <7.7 group, the hazard ratios for a liver-related outcome at 5 years were 21.00 (95% CI, 2.68–164.65) and 71.04 (95% CI, 9.4–536.7) in the 9.8 to <11.3 and ≥11.3 subgroups, respectively.

Conclusion: The selection of standard thresholds for detection and prognosis of liver fibrosis is described and their performance reported. These thresholds should prove useful in both interpreting and explaining test results and when considering the relationship of ELF score to Ishak stage in the context of monitoring.

Role of Sponsor: The funding organizations played no role in the design of study, choice of enrolled patients, review and interpretation of data, preparation of manuscript, or final approval of manuscript.

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